PRODUCT INFORMATION AND INSTRUCTIONS OM-411A OM-411AF

PRODUCT INFORMATION AND INSTRUCTIONS OM-411A OM-411AF

TABLE OF CONTENTS 1 General Information.............................................. 2 Important Safety Rules and Precautions.............................. 3-4 Introduction..................................................... 5 Description of Parts and Controls... 6-8 Assembly and Use Non-Portable Use............................................ 9 Installing the Battery......................................... 10 Installing the System......................................... 11 Operating Instructions... 11-12 Continuous Flow Adjustment Procedures......................... 13 Oxygen Cylinder Duration...14 Care and Maintenance...15 Troubleshooting Guide....16 Classifications....17 Specifications... 18-19 Symbols Key............................................... 19 Limited Warranty...20 Important Information to Record.................................... 21 Notes......................................................... 22

GENERAL INFORMATION This manual provides information necessary to operate the OXYMATIC electronic oxygen conserver with built-in regulator in accordance with a physician s prescription. The OXYMATIC conserver can be used with any CGA 870 post-valve cylinder (see Fig. A) at home or away from home to provide your specific oxygen requirements. It requires one (1) 1.5 volt, C-size alkaline battery for operation. Statements in this manual preceded by the following words are of special significance: Cylinder Valve Toggle Parallel Holes on the Post Valve WARNING! Indicates there is a possibility of injury to you or others. FIGURE A Post-Valve Cylinder CAUTION Indicates there is a possibility of damage to the device or to other property. * NOTE Indicates points of particular interest or emphasis that allow for more efficient and convenient operation of the equipment. 2

IMPORTANT SAFETY RULES & PRECAUTIONS WARNING! Read and understand this manual before operating your OXYMATIC electronic oxygen conserver. This device is not intended for use during sleep or by patients who: - Breathe more than 40 breaths per minute, - Consistently fail to trigger equipment (i.e., mouth breathe). Smoking near oxygen equipment is strictly prohibited. Keep cigarettes, matches, burning tobacco and open flames such as lighted candles away from the area where the system is being stored or operated. Avoid creation of any spark, such as static electricity caused by any type of friction, near the oxygen equipment. * NOTE: Oxygen will not burn; however, it does vigorously accelerate the burning of any flammable material. 3 Never use oil, grease, or petroleum-based products on or near the system. Please wash and dry your hands properly prior to operating your oxygen equipment. Never use aerosol sprays near the equipment. Do not use in the presence of flammable anesthetic mixture. Keep your oxygen equipment at least 5 ft. (1.5 m) away from any electrical appliance. Be sure to turn off the oxygen supply by closing the cylinder valve when not in use. Do not use cannula tubing that is longer than 7 ft. (2.13m). Do not use mask, pediatric, or other low-flow cannula tubing when operating the unit.

IMPORTANT SAFETY RULES & PRECAUTIONS CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Prevent water or other liquid substances from entering the unit. Prevent dust or any small particles from entering the unit. Do not expose the unit to extreme temperatures. Be sure to carry an extra C-size alkaline battery in the event it is needed. Always maintain a backup supply of oxygen. Do not use humidifier bottles. Do not use if leaking or damaged. Refer repairs to authorized service personnel. * NOTE: Oxygen supplied by this equipment is supplemental only and is not intended for life support applications. Please contact your Home Care Provider if you have any questions. 4

INTRODUCTION The OXYMATIC electronic oxygen conservers include a combination of a lowpressure regulator and an oxygen conserver. They are designed for use with ambulatory oxygen systems and are capable of delivering a precise amount of supplemental oxygen at the optimal point in the breathing cycle. Operationally, the OXYMATIC conservers greatly increase efficiency in the delivery of oxygen, maximizing the beneficial effects and eliminating unnecessary oxygen waste. When we breathe, approximately one-third of the time is spent inhaling and twothirds exhaling. As a result, oxygen delivered by continuous flow is wasted during exhalation. By eliminating oxygen flow during exhalation, a two-thirds savings is possible. Additionally, the oxygen available during the very first part of inhalation contributes most to meeting oxygen needs. The OXYMATIC conservers take advantage of these facts to provide maximum efficiency in the delivery of oxygen. These devices are designed to be an integral component of a lightweight, longlasting ambulatory oxygen system. 5

DESCRIPTION OF PARTS & CONTROLS Oxygen Pressure Gauge Cylinder Adjustment Knob Oxygen Supply Outlet Battery Test Indicator Light FIGURE B OXYMATIC Top View Selector Knob Battery Test Indicator Light: The OXYMATIC conservers incorporate a visual indicator light (multi-color LED) that monitors the battery energy level inside the unit by displaying three colors. 1) Green - adequate battery energy level for operation. 2) Amber - lower battery energy level but still in the operational range. 3) Red - low battery energy level. A spare C-size alkaline battery should be readily available. 4) Flashing Red - Replace battery immediately. Cylinder Adjustment Knob: This is used to attach the unit to any CGA 870 post-valve cylinder. 6

DESCRIPTION OF PARTS & CONTROLS Selector Knob: This enables the user to select the prescribed liter flow setting (1-6). It also enables the user to monitor the battery energy level. When not in use, the switch should be turned to the OFF position. Battery Holder: This compartment holds one (1) C-size alkaline battery (See Fig. E on page 10). Oxygen Pressure Gauge: This enables the user to monitor the contents of the compressed oxygen cylinder. Oxygen Supply Outlet: Use this fitting to attach a standard cannula. Cylinder Alignment Pins: When assembling the unit, these parallel pins must go in the holes on the post valve (See Fig. C on page 8). CGA Seal (Gasket, FR-870G, brass and viton) or equivalent: This creates the interface between the post valve and the OXYMATIC conservers. Besides offering a rugged interface, it also surrounds the oxygen path in a ring of stainless steel or brass (See Fig. C on page 8). WARNING! Use only a manufacturer-specified gasket. 7

DESCRIPTION OF PARTS & CONTROLS Bypass Switch: This is a pneumatic switch that enables the user to switch from pulse mode (oxygen delivery on demand) to continuous flow mode (preset at 2 lpm) in the unlikely event of unit malfunction. Continuous flow mode is not powered by the battery and can be utilized without one. Bypass Switch Cylinder Alignment Pins FIGURE D OXYMATIC Bottom View FIGURE C OXYMATIC Oxygen Inlet Connection CGA Seal (Gasket, FR-870G) * NOTE: Remember that in continuous flow mode, the oxygen will be consumed at a much faster rate. Return to another source before depleting the oxygen cylinder. CAUTION: The Bypass Switch is designed for emergency use only. In the event that it is necessary to operate the unit in continuous flow mode, DO NOT obstruct the flow of oxygen from the Oxygen Supply Outlet by placing your finger over the outlet or blocking the flow through the oxygen tubing in any way. Doing so may render the unit inoperable and/or damage the sensor in the unit. * NOTE: The continuous flow mode on model OM-411A is permanently preset at 2 lpm. Model OM-411AF is factory preset at 2 lpm and adjustable between.5 and 6 lpm by your Home Care Provider (see Continuous Flow Adjustment Procedures on page 13). 8

ASSEMBLY AND USE Make certain that your hands are free of oil, grease, and other contaminants. Inspect the unit to insure that it has a CGA 870 brass and viton (or equivalent) gasket in good working condition attached to the inlet nozzle. Secure the cylinder in an upright position. Inspect the post valve of the cylinder and the OXYMATIC conserver to ensure they are free of contaminants. If any indication of damage or contamination is detected, DO NOT use the equipment and contact your Home Care Provider. WARNING! Use ONLY a manufacturer-specified gasket. Other gaskets may not be oxygen compatible and may cause an oxygen leak, creating an increased fire risk. NON-PORTABLE USE: The OXYMATIC conservers are designed to extend the life of portable oxygen supplies when away from the primary source. While the OXYMATIC conservers may be used with stationary oxygen sources, they should be used only while awake and reasonably attentive. The OXYMATIC conservers are not intended for use while asleep because in the unlikely event of operational malfunction or dislodging of the cannula the user could be unaware and not make the necessary corrections. 9

ASSEMBLY AND USE INSTALLING THE BATTERY: While holding the unit with one hand, press in and lift up on the battery holder latch. Press the battery into the slot, making sure it is placed over the battery release strap and inserted in the proper direction [Fig. E]. The battery should fit snugly into the unit. Be sure that the battery makes firm contact at the positive (+) side. FIGURE E Installing the battery Battery release strap * NOTE: The OXYMATIC conservers are packaged with a battery inside. A special seal is used at the positive terminal to prevent battery oxidation. If it has not already been removed by your Home Care Provider, be sure to remove the seal when using the unit for the first time. Close the battery holder cover by snapping it back into place. Verify that the battery is charged by turning the selector knob to the battery position. (as indicated by the battery symbol ). * NOTE: The battery indicator light is inoperative except when the selector knob is in the battery position; however, the red light will flash in any setting if the battery needs to be replaced. Always check the battery energy level before using. With normal use of 8 hours per day, a battery should last about 4 weeks. 10

ASSEMBLY AND USE INSTALLING THE SYSTEM: Loosen the cylinder adjustment knob. Lower the OXYMATIC conserver over any post-valve cylinder with the alignment pins toward the holes on the cylinder neck [Fig. F]. Align the two pins and gasket with the corresponding holes on the cylinder post valve. While holding the unit in place, tighten the cylinder adjustment knob by turning clockwise [Fig. F]. Attach a standard cannula (7ft. (2.13 m) or less in length) to the oxygen supply outlet. FIGURE F Attaching the OXYMATIC conserver to the cylinder 11 * NOTE: Tighten only by hand. The use of a tool to tighten the knob may damage the unit. OPERATING INSTRUCTIONS: Make sure the bypass switch is set to Pulse Mode, and the Oxymatic conserver is set to the OFF position. To reduce the risk of rapid oxygen recompression and fire, open the cylinder valve slowly and completely so that the pressure gauge moves slowly as it indicates the cylinder pressure. Listen for leaks. If a leak is present, close the cylinder valve, check the CGA seal, and reinstall. If the leak persists, DO NOT USE THE EQUIPMENT. Contact your Home Care Provider for repair. CAUTION: If you are unable to eliminate leaks by manually tightening the cylinder adjustment knob, replace the CGA 870 gasket. If leaks persist, the unit must be returned for service.

ASSEMBLY AND USE OPERATING INSTRUCTIONS continued: Turn the selector knob to the battery position (as indicated by the battery symbol ). Check the battery indicator: 1) Green - Good 2) Amber - Consider replacing the battery 3) Red, Flashing Red, or No Indicator - Replace the battery Select the setting on the OXYMATIC conserver (1-6) that corresponds to the appropriate delivery setting. Place the nasal cannula into position with the prongs in the nostrils and begin breathing. The OXYMATIC conserver will now start to deliver the oxygen. A click sound may be heard each time the unit delivers a pulse of oxygen. Adequate oxygen delivery will be achieved because of the precise time in the breathing cycle that the pulse of oxygen is delivered. * NOTE: To help prevent possible damage to the unit, keep the OXYMATIC conserver in a carrying bag. Several bags are available for use with different cylinder sizes and configurations. When finished using the system, turn off the oxygen supply cylinder valve and continue breathing through the nasal cannula until no further oxygen is detected. Remove the nasal cannula and turn the selector knob to the OFF position. When not in use, store in a clean, dry location. 12

ASSEMBLY AND USE CONTINUOUS FLOW ADJUSTMENT PROCEDURES FOR MODEL OM-411AF: To adjust the continuous flow rate on the OXYMATIC Model OM-411AF: 1. With the unit connected to a cylinder, change the unit to continuous flow mode by flipping the switch on the underside of the conserver. 2. Locate the adjustment valve near the continuous flow lever. [Fig. A] 3. Attach a flow meter to the outlet port of the conserver [Fig. B] 4. Using a small jeweler s-type screwdriver, adjust the screw until the desired flow rate between 0.5 and 6 lpm registers on the flow meter. Turning counterclockwise will increase the flow and turning clockwise will decrease the flow. * NOTE: Due to the varying accuracy of flow meters, we recommend the continuous flow be set at no less than 0.5 lpm. * NOTE: The unit is factory preset to 2 lpm. If a continuous flow of 2 lpm is desired, no adjustment is necessary. Figure A Figure B 13

OXYGEN CYLINDER DURATION Because the total delivery of oxygen via the OXYMATIC conserver is related to breathing rates, it is user adaptive in that the total oxygen delivered per minute will automatically adjust with user need, as expressed by increased or decreased breathing rates. For example, at all settings twice as much oxygen per minute will be delivered if one breathes twenty (20) times per minute as compared with ten (10) times per minute. Table 1 provides useful information to be used as a guide. SETTING 1 2 3 4 5 6 CYLINDER TYPE CYLINDER VOLUME Estimated Cylinder Duration in Hours (Based on 20 breaths/min) TABLE 1 Continuous Flow 2lpm M2 36 liters 3.0 1.5 1.0 0.8 0.6 0.5 0.3 M4(A) 113 liters 9.4 4.7 3.1 2.4 1.9 1.6 0.9 M6(B) 164 liters 13.7 6.8 4.6 3.4 2.7 2.3 1.4 ML6 171 liters 14.3 7.1 4.8 3.6 2.9 2.4 1.4 M7 198 liters 16.5 8.3 5.5 4.1 3.3 2.8 1.7 M9(C) 246 liters 20.5 10.3 6.8 5.1 4.1 3.4 2.1 D 425 liters 35.4 17.7 11.8 8.9 7.1 5.9 3.5 E 680 liters 56.7 28.3 18.9 14.2 11.3 9.4 5.7 14

CARE AND MAINTENANCE The OXYMATIC conservers are designed for a long and accurate life; however, as with any electronic device, normal prudent care is required. The units should be kept clean and free from moisture and dust, as well as extreme temperature. Do not expose the unit to water, such as when bathing or swimming. It is advisable to keep the device in its carrying bag to afford a degree of protection. Clean the outside cover periodically by wiping with a lint-free cloth. Pay special attention to the oxygen inlet and outlet to make sure they remain free of dust, etc. If the oxygen inlet connection (CGA-870) becomes contaminated with dirt, oil or grease, DO NOT USE OR ATTEMPT TO CLEAN. Contact your Home Care Provider for service or repair. Cannula tubing is a disposable accessory that should be replaced periodically following normal usage. Disposable tubing should be disposed of in accordance with local ordinances and/or regulations for disposal. Replacements are available through your Home Care Provider (OC-501, case of (50) 5 ft. [1.52 m] cannulas or equivalent). 15

TROUBLESHOOTING GUIDE PROBLEM PROBABLE CAUSE SOLUTION Dead battery. Replace battery. Unit does not pulse. Short battery life. Battery installed incorrectly (reversed). Dirty battery holder contacts. Cylinder valve is closed. Cylinder is empty. Oxygen cannula is blocked or kinked. Non-alkaline battery is used. Make sure battery polarity is correct. Remove the battery. Use alcohol and a cotton swab to clean both contacts. Turn the cylinder valve to the ON position. Check the oxygen gauge. Replace the cylinder, if empty. Remove kinks. Clean or replace, if necessary. Make sure the battery inside the unit is alkaline. Energizer, Ray-O-Vac or Duracell batteries are recommended. Non-functioning units are subject to warranty provisions and the manufacturer repair/return policy. If necessary, call your Home Care Provider. * NOTE: Do not attempt to open the electronic compartment of the unit. If the case is opened or tampered with, the warranty is void. 16

CLASSIFICATIONS The OXYMATIC conservers are classified as: Class II, per FDA 21 CFR Part 868.5905. Internally Powered Equipment - EN 60601-1. Ordinary Equipment - Enclosed equipment without protection against ingress of water - EN 60601-1. Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. Complies to EN 60601-1-2 electromagnetic testing. Type BF equipment. 17

SPECIFICATIONS Oxygen Delivery: Switch Position Liter Flow Equivalency 1 1 2 2 3 3 4 4 5 5 6 6 Continuous Flow Emergency Bypass Setting: OM-411A: Factory preset at 2.0 lpm +.5 lpm OM-411AF: Factory preset at 2.0 lpm +.5 lpm, provider-adjustable between.5 and 6 lpm Required Operating Pressure: Regulator: Voltage: Battery: 200 psi to 3000 psi (13.8 bar to 206.8 bar) Built-in, aluminum body regulator containing brass components preset at 25 + 5 psi (1.7 +.34 bar) 1.03 V to 1.65 V 1.5 VDC alkaline C-size Battery Indicator: Green: Good Amber: Low battery energy level, but still in operational range Red: Replace Flashing Red: Replace immediately Power Consumption: <20 ma at idle time and maximum of 600 ma during delivery time Dimensions: Approximately 6 L x 2 H x 4 W (15.2 cm L x 5.1 cm H x 10.2 cm W) Weight: Approximately 1.0 lbs (454 grams) without battery and approximately 1.1lbs (499 grams) with battery 18

SPECIFICATIONS Operating Temperature: 32 F to 122 F (0 C to 50 C) Operating Relative Humidity: 15% to 95% Operating Altitude: 0 to 10,000 feet (0 to 3,048 meters) Storage/Transportation: Cold temperature: Hot temperature: Maximum -40 F (-40 C), 1% RH Maximum 145 F (63 C), 44% RH Shock: Not to exceed IEC 601-1 requirements Vibration: Not to exceed IEC 68-2-6, IEC 68-2-34 SYMBOLS KEY: : No smoking or open flames : WARNING! Consult accompanying documents. : System ON : System OFF : Type BF equipment 19

LIMITED WARRANTY The OXYMATIC electronic oxygen conserver has been carefully manufactured and inspected and is warranted to be free from defects in workmanship and materials. Under this warranty, CHAD Therapeutics obligation shall be limited to the replacement or repair of any such units or parts that prove, by CHAD s inspection, to be defective within two years from the date of purchase. Any abuse, operation other than the intended use of the product, negligence, accident or repair by other than authorized service professionals shall immediately void this warranty. This warranty does not extend to the cannula or battery. CHAD Therapeutics will not accept damages or charges for labor, parts or expenses incurred in making field repairs, except upon written authorization prior to such action. The foregoing warranty is exclusive and in lieu of all other express warranties. Implied warranties, if any, including but not limited to the implied warranties of merchantability and fitness for a particular purpose, shall not extend beyond the duration of the express warranty provided herein. In no event shall CHAD Therapeutics be liable for loss of use or profit or other collateral, special or consequential damages. 20

IMPORTANT INFORMATION TO RECORD Your Name: Date You Received Your Unit: Prescribed Oxygen Flow Setting: At Rest: During Exercise: Home Care Provider s Name: Home Care Provider s Phone Number: ( ) Physician s Name: Physician s Phone Number: ( ) Notes: 21

NOTES 22

Manufactured by Inovo, Inc. 2975 Horseshoe Drive South, Suite 600 Naples, FL 34101 Toll-free: 800-423-8870 Local: 239-687-1280 Fax: 239-687-1285 International Phone: +01-818-701-1008 International Fax: +01-818-701-1913 www.chadtherapeutics.com Authorized Representative According to MDD 93/42/EEC MDSS Schiffgraben 41 30175 Hannover, Germany United States Patent Number # 5,134,886 P/N #3080261/09/T Printed in the U.S.A. OXYMATIC and CHAD are registered trademarks of Inovo, Inc.